Drug and pharmaceutical recalls
17730 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2018-01-10FDA-DrugFresenius Kabi USA, LLCClass IMidazolam Injection, USP, Preservative Free, 2 mg / 2 mL (1 mg / mL), 24 X 2mL Prefilled single-use syringes per carton, Rx only, Fresenius Kabi Lake Zurich, IL 60047, NDC 76045-001-20
Labeling: Label MIX-UP. Blister Packages, Labeled as Midazolam injection, USP, 2 mg / 2 ml, Containing Syringes of Ondansetron Injection, USP, 4 mg / 2 mL
- 2018-01-10FDA-DrugPfizer Inc.Class IIZoloft (sertraline HCl) tablets 25 mg* 30-count bottle, Rx only, Distributed by Roerig Division of Pfizer Inc., NY, NY, 10017 NDC 0049-4960-30
SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent
- 2018-01-10FDA-DrugPfizer Inc.Class Idiphenoxylate hydrochloride and atropine sulfate tablets, USP, 2.5 mg/0.025 mg, a) 100-count bottle (NDC 59762-1061-1), b) 1000-count bottle (NDC 59762-1061-2), Rx Only, Distributed by: Greenstone LLC. Peapack, NJ 07977
SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent
- 2018-01-10FDA-DrugNatures SupplementClass IEnhanced Vegetal Vigra 200 mg Capsules, 8 count bottles, Manufacturer: Hand-shaking (Int'l) Cop. USA, ADD: Hand-shaking Mansion, the 5th Ave., Stanford, USA --- UPC# 8931028556885
Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with Sildenafil.
- 2018-01-03FDA-DrugSSM Health Care St. Louis DBA SSM St. Clare Health CenterClass IISuccinylcholine chloride 100 mg in 5 mL syringe, Concentration: 20 mg/mL. This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO --- NDC: 88890-7536-01
Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
- 2018-01-03FDA-DrugSSM Health Care St. Louis DBA SSM St. Clare Health CenterClass IIPhenylephrine 1000 mcg in 0.9% Sodium Chloride 10 mL, 10 mL syringe, Concentration: 100 mcg/mL. This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO --- NDC: 88890-0104-01
Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
- 2018-01-03FDA-DrugSSM Health Care St. Louis DBA SSM St. Clare Health CenterClass IIOxytocin 30 units in 0.9% Sodium Chloride 500 mL, 500 mL IV Bag, Concentration: 0.06 units/mL. This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO --- NDC: 88890-0903-01
Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
- 2018-01-03FDA-DrugSSM Health Care St. Louis DBA SSM St. Clare Health CenterClass IINorepinephrine 8 mg in dextrose 5% 250 mL, 250mL IV Bag, Concentration: 0.032 mg/mL, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, , Fenton, MO --- NDC: 88890-0334-01
Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
- 2018-01-03FDA-DrugSSM Health Care St. Louis DBA SSM St. Clare Health CenterClass IINeostigmine Methylsulfate 5 mg/5 mL, 5 mL Syringe, Concentration: 1 mg/mL. This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO --- NDC: 88890-0329-01
Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
- 2018-01-03FDA-DrugSSM Health Care St. Louis DBA SSM St. Clare Health CenterClass IIMorphine 50 mg in 0.9% Sodium Chloride 5 mL PCA, 50 mL Cartridge, Concentration: 1 mg/mL, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88887-6795-01
Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
- 2018-01-03FDA-DrugSSM Health Care St. Louis DBA SSM St. Clare Health CenterClass IIHYDROmorphone 10 mg in 0.9% Sodium Chloride 50 mL PCA, 50 mL Cartridge, Concentration: 0.2 mg/mL., This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88883-0600-01
Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
- 2018-01-03FDA-DrugSSM Health Care St. Louis DBA SSM St. Clare Health CenterClass IIFentanyl 2 mcg/mL and ropivacaine 0.2% in 0.9% Sodium Chloride 150 mL, 150 mL bag, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88883-4272-01
Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
- 2018-01-03FDA-DrugSSM Health Care St. Louis DBA SSM St. Clare Health CenterClass IIAmiodarone 900 mg in dextrose 5% 500 mL, 500 mL bag, Concentration: 1.8 mg/mL, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88890-0333-01
Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
- 2018-01-03FDA-DrugSSM Health Care St. Louis DBA SSM St. Clare Health CenterClass IIFentanyl 10 mcg in 0.9% Sodium Chloride 1 mL, 1 mL Vial, Concentration: 10 mcg/mL, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88890-9010-81
Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
- 2018-01-03FDA-DrugBayer HealthCare Pharmaceuticals, Inc.Class IIIBayer Chewable Low Dose Aspirin 81 mg Orange Flavored 36 tablets, Made in Spain, Distributed by: Bayer Healthcare LLC Morristown, NJ 07962 NDC 0280-2160-36 UPC 3128431310577
Failed Stability Specifications
- 2018-01-03FDA-DrugSimple Diagnostics, Inc.Class IIAlcohol Prep Pads (Isopropyl Alcohol USP 70% v/v), 100 Individual Pads, Sterile, Distributed by Simple Diagnostics, Winston Park, NY NDC 98302-0001-05
Lack of Assurance of Sterility and cGMP Deviations
- 2018-01-03FDA-DrugKeryx Biopharmaceuticals, Inc.Class IIIAuryxia (ferric citrate) tablets, 210 mg , 200-count bottles, RX ONLY, Manufactured for and distributed by: Keryx Biopharmaceticals, Inc. One Marina Park Drive, 12th Floor, Boston, MA 02210 USA. NDC 59922-631-01
Presence of Foreign Substance: Reports have been received of damaged StripPax packets containing silica gel desiccant potentially allowing the silica gel granules to make contact with Auryxia tablets in the bottle.
- 2018-01-03FDA-DrugPharmedium Services, LLCClass IIIHYDROmorphone HCl in 0.9% Sodium Chloride Injection, 1 mL Total Volume 1 mg per mL, For IV Use Only, Rx Only, Compounded by: PharMEDium Services LLC. 913 N Davis Ave Cleveland, MS 38732, NDC# 61553-165-78
Labeling: Incorrect or Missing Lot and/or Exp. Date
- 2018-01-03FDA-DrugPharmedium Services, LLCClass IIImorphine Sulfate in 0.9% Sodium Chloride Injection 1 mL Total Volume 2 mg per mL , For IV Use, Rx Only, Compounded by: PharMEDium Services LLC. 913 N Davis Ave Cleveland, MS 38732, NDC# 61553-455-78
Labeling: Incorrect or Missing Lot and/or Exp. Date
- 2018-01-03FDA-DrugPharmedium Services, LLCClass IIImorphine Sulfate in 0.9% Sodium Chloride Injection 2 mL Total Volume 1 mg per mL (2 mg per 2 mL), For IV Use, Rx Only, Compounded by: PharMEDium Services LLC. 913 N Davis Ave Cleveland, MS 38732, NDC# 61553-259-28
Labeling: Incorrect or Missing Lot and/or Exp. Date
- 2017-12-27FDA-DrugVital Rx, Inc. dba Atlantic Pharmacy and CompoundingClass IIAll Sterile Products within expiry
Lack of Assurance of Sterility .
- 2017-12-27FDA-DrugPremier Pharmacy Labs IncClass IINeostigmine Methylsulfate (single dose syringe) 1 mg per mL 5 mg per 5 mL Injectable Hospital/Office Use Only Compounded by: Premier Pharmacy Labs., Inc. 8265 Commercial Way Weeki Wachee, FL 34613, NDC# 69623-234-15
Stability Date Doesn't Support Expiry: labeling error indicating a beyond use date that exceeds current stability data.
- 2017-12-27FDA-DrugL. Perrigo CompanyClass IIMaximum Strength Zephrex-D, Pseudoephedrine HCl, 30 mg, Nasal Decongestant. 24 softgel tablets per paper carton, Distributed by Perrigo, Allegan, MI 49010, NDC 70085-151-01
Microbial Contamination of Non-Sterile Products
- 2017-12-27FDA-DrugClaris Lifesciences IncClass IIICiprofloxacin in Dextrose (5%) Injection, USP 200 mg in 100 mL 5% Dextrose, Rx Only, (2 mg/mL), 100 mL Flexible Bag, Manufactured for: Claris LifeScience Inc. North Brunswick NJ 08902 by Claris Injectables Ltd. Gujarat, India UPC 336000008242 NDC 36000-008-249
Superpotent
- 2017-12-27FDA-DrugThe Ampt Life, LLCClass INATURAL HERBAL COFFEE AMPT, sold in 25g packages (UPC 6942630905), 10-count packages per box (UPC 6942630912); Manufactured For: The Ampt Life, LLC.
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared sildenafil and tadalafil and undeclared milk. The presence of sildenafil and tadalafil makes AMPT Natural Herbal Coffee an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall. Additionally, this product has been found to contain undeclared milk, milk is recognized as one of the foods reported to have caused deaths due to anaphylactic shock in persons with underlying hypersensitivities.
- 2017-12-27FDA-DrugTeva Pharmaceuticals USAClass IIAmethyst (Levonorgestrel and Ethinyl Estradiol Tablets USP, 90mcg/20mcg), 28 tablet dispenser (blister foil unit), Rx only, Manufactured by: Warner Chilcott Company, LLC Fajardo, Puerto Rico 00738: Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA, NDC-52544-295-28
Labeling: Incorrect Instructions. "TABLETS IN WEEK 4 ARE INACTIVE" printed on the blister foil and package insert, however,all tablets are active.
- 2017-12-27FDA-DrugRenaissance Lakewood, LLCClass IIIFluconazole Injection, USP, 2 mg/mL, a) 50 mL (NDC 336000-261-10) and b) 100 mL (NDC 33600-002-10), Rx Only, Manufactured for: Claris LifeSciences, Inc. North Brunswick, NJ 08902 By: Claris Injectables Ltd., Gujarat, India
Superpotent
- 2017-12-27FDA-DrugPfizer Inc.Class IVancomycin Hydrochloride for Injection, USP. 750 mg. Sterile Powder. Rx Only. Hospira, Inc., Lake Forest, IL 60045 USA. NDC: 0409-6531-02
Presence of Particulate Matter: glass particulate found in vial
- 2017-12-27FDA-DrugEZWeightLossTX LLCClass ILaBri's Body Health XPLODE 30 capsules Exclusively distribute worldwide by LaBri's Body Health.
Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplements: products found to be tainted with sibutramine making these unapproved drugs.
- 2017-12-27FDA-DrugEZWeightLossTX LLCClass ILaBri's Body Health Atomic 60 Capsules Exclusively distributed worldwide by LaBri's Body Health.
Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplements: products found to be tainted with sibutramine making these unapproved drugs.
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